China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT05514210
This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.
Time frame: At 1 year after the coronary angiography
a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.
Time frame: through treatment completion, an average of 60 days
time interval is considered as a key secondary outcome
Time frame: through study completion, an average of 1 year
to assess the distribution of the revascularization decision-making made jointly by the heart team and the patients, such as CABG, PCI or medical therapy
Time frame: through study completion, an average of 1 year
adjudicated according to 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guideline
Time frame: through study completion, an average of 1 year
to assess the distribution of the decision-making made by the heart team, such as CABG, PCI or medical therapy
Time frame: through study completion, an average of 1 year
to assess the workload of the specialists participating in the heart team meetings by NASA-TLX scale
Time frame: through study completion, an average of 1 year
to assess the successful-connection with cardiac surgeons during or after the coronary angiography
Time frame: through study completion, an average of 1 year
to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital
Time frame: through study completion, an average of 3 year
to assess the total cost in hospital for the initial hospitalization and rehospitalization
Time frame: At 1 year after the coronary angiography
including all-cause death, cardiac death, myocardial infarction, stroke, revascularization of target vessels or transplanted vessels, revascularization for any reason, be admitted to hospital with angina again, readmission for cardiac reasons and readmission for any reason
China National Center for Cardiovascular Diseases
Other Gov
Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
Acronym: EHEART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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